Endoscope and method of use

ABSTRACT

An endoscope includes a shaft assembly having proximal and distal ends and a longitudinal axis therebetween. A handle is coupled to the proximal end of the shaft assembly, and an elastomeric body housing an image sensor and at least one LED is comprises a distal end of the shaft. The elastomeric body is deformable between a repose straight insertion profile and a deflected offset profile by the insertion of a tool shaft through the shaft assembly and an expandable-collapsible working channel in the elastomeric body. The viewing angle of the image sensor is moved from a first selected angle to a second selected angle when the elastomeric body is actuated from the repose profile to the deflected offset profile.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/848,050 filed Apr. 14, 2020, which claims benefit of U.S. provisionalapplication No. 62/835,917 filed on Apr. 18, 2019, the entirety of eachof which is incorporated by reference. This application is also relatedto PCT application PCT/US2020/028062 filed Apr. 14, 2020, the entiretyof which is incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention. The present invention relates generally tomedical devices and methods. More particularly, the present invention isrelated to endoscopic systems suitable for hysterectomy and otherpurposes.

Endoscopic systems of the invention intended for hysterectomy typicallycomprise a base station having an image display, a disposable endoscopecomponent with an image sensor, a re-usable handle component that isconnected to an image processor in a base station, and a fluidmanagement system integrated with the base station and handle component.The endoscope component and the re-useable handle are typically referredto as a hysteroscope.

Of particular interest to the present invention, hysteroscopes and otherendoscopes provide for the introduction of interventional tools througha working channel in the shaft of the scope. The size of the workingchannel of a hysteroscope is limited by the need to introduce at least adistal portion of the shaft through the patient's cervix.

Of further interest to the present invention, hysteroscopes may have ashaft rotatable relative to the handle, and that shaft will often carrya camera and light source that need to be externally connected throughthe handle.

Of still further interest to the present invention, rotatablehysteroscope shafts may also carry fluids through a lumen which has anexternal port fixed in the handle.

For these reasons, it would be desirable to provide improvedhysteroscopes which can accommodate the introduction of comparativelylarge tools through a shaft with a relatively low profile. It would befurther desirable to provide improved hysteroscopes which canaccommodate the connection of cameras, light sources, and the like, onrotatable shafts through stationary handles. It would be still furtherdesirable to provide improved hysteroscopes which can accommodate theflow of fluids through rotatable shafts coupled to stationary handles.At least some of these objectives will be met by the inventionsdescribed hereinbelow.

Hysteroscopic systems of a type similar to that illustrated herein aredescribed in commonly owned, co-pending applications: Ser. No.15/712,603; Ser. No. 15/836,460; Ser. No. 15/861,474; and Ser. No.15/975,626, the full disclosures of which are incorporated herein byreference.

SUMMARY OF THE INVENTION

In a first aspect of the present invention, a hysteroscope or otherendoscopic system comprises a shaft having an outer shaft diameter, adistal shaft portion, a proximal shaft portion, and a longitudinal axisthere between. A handle is coupled to the proximal portion of the shaft,and an image sensor with a diagonal dimension is carried by the distalportion of the shaft. A channel extends through at least the distalshaft portion and has a channel diameter. A section of the channel inthe distal portion of the shaft is re-configurable between a constrictedshape or geometry and a non-constricted shape or geometry to accommodatea tool introduced there through. Because of the re-configurable natureof the distal portion of the channel, the combined diagonal dimensionand channel diameter may be greater than the outer shaft diameter. Thehandle will typically be detachably coupled to the shaft so that thehandle is reusable and the shaft is disposable, but at least someaspects of the present invention will be found in endoscopes comprisingfixed handle-shaft structures as well.

In certain exemplary embodiments of the endoscopes of the presentinvention, the diagonal dimension will be at least 50% of the outershaft diameter, typically being at least 60%, or greater. In furtherexemplary embodiments, the channel diameter will also be at least 50% ofthe outer shaft diameter, more often being at least 60% of the outershaft diameter, or greater.

In other exemplary embodiments, the endoscopes of the present inventionwill be provided in systems which further comprise a fluid inflow sourcefor providing fluid flow through an inflow channel in the shaft to anoutlet in the distal portion of the shaft. Usually, such systems willfurther comprise a negative pressure source for providing fluid outflowsthrough the outflow channel in the shaft and an opening in the distalshaft portion. Still further, the systems may comprise a controller forcontrolling fluid flows through the inflow and outflow channels and atleast one actuator in the handle for adjusting fluid inflows andoutflows. For example, the controller may be configured with algorithmsfor operating the fluid inflow source and the negative pressure sourceto maintain fluid within a set pressure range in a working space, suchas the uterine cavity.

In a second aspect of the present invention, a hystero scope or otherendoscope comprises a handle having an interior, an axis, and anelectrical connector fixed to the handle. A shaft is removably orotherwise coupled to the handle and configured to rotate, typicallyreversibly rotate, about a longitudinal axis relative to the handlethrough an arc of about 180° or greater. An electronic image sensor iscarried at a distal end of the shaft, and one or more electrical leadsextend from the image sensor to the electrical connector in the handle.The electrical lead(s) are flexible and configured with a “slack”portion in the interior of the handle to accommodate rotation of theshaft. By “slack,” it is meant that the length of the electrical lead(s)is greater than the distance between the electrical connector and thepoint of attachment of the electrical lead(s) to the shaft so that theshaft may be rotated without over tensioning the electrical lead(s).

In further exemplary embodiments of this endoscope, the slack portionmay be formed as any one of a coil, a spiral, a folded structure, aserpentine structure, or the like. In specific embodiments, one end ofthe slack portion will be coupled to and extend around the axis of therotating shaft assembly, typically being carried on a spool secured tothe shaft assembly. The spool is usually aligned concentric orco-axially with the axis of the shaft so that as the shaft is rotated,the spool may take up or let out the flexible electrical leads asneeded. In specific examples, the electrical leads may comprise the flexcircuits.

In still further exemplary embodiments of these endoscopes, a lightemitter may be carried at the distal end of the shaft and secondelectrical lead(s) may extend from the light emitter to a secondelectrical connector fixed in the handle. The second electrical leadsare configured with a second slack portion to accommodate rotation ofthe shaft. The second shaft portion may also be carried on a secondspool and may comprise a flex circuit.

In still further aspects of this endoscope, a channel may be formed inthe shaft where a portion of the channel is re-configurable between aconstricted shape and a non-constricted shape to accommodateintroduction to a tool through the channel. As with the first endoscopicembodiments described above, the combined diagonal dimension and channeldiameter will typically be greater than an outer shaft diameter. Otherspecific aspects of the re-configurable channel described above withrespect to the earlier embodiment may also be found in the endoscopes ofthe second aspect herein.

In the third aspect of the present invention, an endoscope comprises ahandle and an elongated shaft. The elongated shaft is mounted to rotate,typically reversibly, at least 180° about a longitudinal axis of thehandle. An electronic image sensor is carried near a distal end of theshaft, and electrical leads extend from the image sensor to the handle.The electrical leads are configured to coil and uncoil (spool andunspool) over the shaft as the shaft is rotated in opposite directionsabout the longitudinal axis. In specific embodiments of this thirdendoscope structure, the electrical leads may comprise a flex circuitand at least a portion of the flex circuit may have a cross-sectionalarea that is less than 5% of the cross-sectional area of the shaftassembly.

In a fourth aspect of the present invention, an endoscope comprises ahandle in an elongated shaft mounted to rotate by at least 180° about alongitudinal axis of the handle. A flow channel extends though the shaftassembly to a port in a distal end of the shaft. The flow channel has aproximal channel portion fixed in the handle and a distal channelportion that rotates together with the shaft. A fluid-tight housingintermediate the proximal and distal channel portions is configured toprovide a fluid-tight path through the channel portions within the fullrotational range of the shaft.

In specific aspects of the fourth endoscope of the present invention,the rotating shaft may include an annular flow channel that rotates inthe housing. The endoscope may still further include a second flowchannel extending through the handle and shaft assembly, where thesecond flow channel has a proximal channel portion fixed in the handlecomponent and a distal channel portion that rotates in the shaft as theflow channel rotates in the housing.

BRIEF DESCRIPTION OF THE DRAWINGS

Additional aspects of the invention will become clear from the followingdescription of illustrative embodiments and from the attached drawings,in which:

FIG. 1 illustrates components of a hysteroscopic treatment systemcorresponding to the invention, including a perspective view of anendoscopic viewing system and schematic view of a fluid managementsystem.

FIG. 2 is a perspective view of the endoscopic viewing system of FIG. 1showing a single-use disposable endoscope component separated from areusable handle component.

FIG. 3A is a perspective view of single-use endoscope component of FIG.2 with the handle shell partially removed to show an interior portion ofthe component.

FIG. 3B is a perspective view of endoscope component of FIG. 3A with aflow channel housing removed to show features of a rotating shaftassembly.

FIG. 4 is a perspective view of the endoscopic viewing system of FIG. 1from a different angle illustrating rotation of the rotating shaftassembly.

FIG. 5 is another perspective and sectional view of endoscope componentof FIGS. 3A-3B with a flow channel housing removed to show the centralaxis of the working channel around which the shaft assembly rotates andthe off-center longitudinal axis of the outer sleeve of the endo scopeshaft.

FIG. 6 is an enlarged perspective view of the endoscopic viewing systemof FIGS. 1 and 2 showing the finger-actuated control panel in thereusable handle component and the sterile and non-sterile fields of thecomponents.

FIG. 7A is an enlarged perspective view of the distal end of theendoscope shaft showing the working channel with a distal channelportion in a reduced cross-sectional configuration for introduction intoa patient's body.

FIG. 7B is another view of the distal end of the endoscope shaft of FIG.7A showing the distal working channel portion in an expandedcross-sectional configuration when a tool is introduced through theworking channel.

FIG. 8 is another view of the distal end of the endoscope shaft assemblyof FIGS. 7A-7B showing the image sensor housing extending distally fromthe distal surface of the outer sleeve tip.

FIG. 9 is another view of the endoscope handle assembly which carries atleast one accelerometer for image orientation.

FIG. 10 is a de-constructed view of the endoscope working end showing aflex circuit configuration.

FIG. 11 is another view of the endoscope working end of FIG. 10.

FIG. 12A is another view of the endoscope working end of FIG. 11 in anon-articulated configuration.

FIG. 12B is another view of the endoscope working end of FIG. 112A in anarticulated configuration.

FIG. 13 is an exploded view of the components of the endoscope workingend of FIGS. 11, 12A and 12B.

FIG. 14 is a perspective view of a housing and lens assembly in thedistal end of an endoscope similar to that of FIGS. 10, 11, 12A and 12Bshowing a single flex circuit with multiple bends or folds therein forcoupling electrical leads to the image sensor and to two LEDs.

FIG. 15 is a perspective view of the distal portion of the flex circuitFIG. 14 in an exploded view showing the insulator layers and conductivelayers of the flex circuit in a planar form showing the multiple leadsthat connect to the image sensor and the LEDs.

FIG. 16 is a perspective view of the proximal portion of the flexcircuit FIG. 15 showing the electrical leads that couple to the circuitboard in the endoscope handle.

FIG. 17A is a perspective view of the distal portion of the flex circuitFIG. 15 after a first folding step where segments of the flex circuitfolded after coupling to the LEDs to orient light emission from the LEDsin a selected direction.

FIG. 17B is a perspective view of the distal portion of the flex circuitFIG. 17A after a second folding step where a portion of the flex circuitis folded orient the image sensor field of view in the distal directionrelative to the shaft of the endoscope.

FIG. 18 is a perspective view of another variation of endoscopic viewingsystem similar to that of FIG. 1 wherein the distal end of the shaftassembly comprises an elastomeric body that carries an image sensor andwherein the elastic body is deformable between the straight repose shapeand a deformed offset shape for providing a working channel therethrough.

FIG. 19A is an enlarged perspective view of the distal end of the shaftassembly of FIG. 18 showing the elastomeric body in a linear, reposeshape.

FIG. 19B is a view of the distal end of the shaft assembly of FIG. 19Ashowing the elastomeric body in an offset, deformed shape that orientsthe angle of view of the image sensor and allows for introduction of atool through a working channel therein.

FIG. 20A is a perspective view of the elastomeric body of FIG. 19Adetached from the remainder of the shaft assembly.

FIG. 20B is a cut-away view of the elastomeric body of FIG. 20 showingthe interior features of the elastomeric body.

FIG. 21 is a perspective cut-away view of another variation with anelastomeric body for carrying the image sensor that is independent of aflexible working channel sleeve that cooperates with the elastomericbody.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a hysteroscopic treatment system 50 corresponding tothe invention which comprises multiple components including anendoscopic viewing system 100 and a fluid management system 105 housedin a base unit or console 108. The base unit 108 also carries acontroller 110A and power source for operating the system 50 and caninclude an image processor 110B for processing signals from an imagesensor carried by the endoscopic viewing system. A display 112 can becoupled to the base unit 108 for viewing images provided by theendoscopic viewing system 100.

More in particular, the endoscopic viewing system 100 of FIGS. 1 and 2includes a re-usable handle component 120 with a finger-actuated controlpad 122 and a disposable single-use endoscope component 125 with anelongated endoscope shaft 126 that carries a distal electronic imagingsensor 128 (see FIGS. 1 and 7A). The fluid management system 105includes a first peristaltic inflow pump 140A and second peristalticoutflow pump 140B, a fluid source 142 and fluid collection reservoir 144which can include a fluid deficit measurement subsystem as is known inthe art. Each of the systems and subsystems will be described in moredetail below.

Referring to FIGS. 1, 2 and 3B, it can be seen that the endoscopicviewing system 100 includes a handle component 120 and a detachablesingle-use endoscope component 125. In FIG. 2, the single-use endoscopecomponent 125 can be seen as an assembly of a proximal handle housing145 which carries a rotating shaft assembly 150 that is configured torotate the handle housing 145.

Referring to FIGS. 1, 3B and 5, the rotating shaft assembly 150 includesa proximal cylindrical grip 152 that is coupled to a molded rotatingcore 155 that in turn is coupled to elongated outer sleeve 160 thatextends to the distal working end 162 the endoscope component 125 (FIG.1). The rotating shaft assembly 150 rotates around a rotational axis165. A working channel 170 extends about axis 165 through the rotatingshaft assembly 150 from a proximal port 172 (see FIGS. 2 and 6). Theworking channel sleeve 174 that carries the working channel 170 can beseen in FIGS. 3A, 3B and 5. Thus, the shaft assembly 150 rotates aboutthe central longitudinal axis 165 of the working channel 170. As can beseen in FIGS. 5 and 7A, the outer sleeve 160 has a central longitudinalaxis 175 that is offset from the longitudinal axis 165 around which theshaft assembly 150 rotates. FIG. 4 shows that the grip 152 has a visualmarker 178 that is aligned with the offset distal tip section 185 toallow the operator to know the orientation of the image sensor 128 byobservation of the grip 152.

In FIGS. 1, 4, 6 and 7A, it can be seen that the endoscope shaft 126 andmore particularly the outer sleeve 160 extends in a straight proximalsleeve portion 180 to an offset distal tip section 185 with an axis 182that is also from 2 to 10 mm offset from the central axis 175 of theouter sleeve 160 (FIG. 7A). The outer sleeve 160 has a transitionsection 186 that extends at an angle ranging between 10° and 45° over alength of 5 to 20 mm between the straight proximal sleeve section 180and the offset distal tip section 185. The imaging sensor 128 isdisposed at the distal end of the offset tip section 185 (see FIG. 7A).As can be seen in FIGS. 5 and 7B, the endoscope component 125 and morein particular the working channel 170 is adapted to receive an elongatetool 188 that can be introduced through the working channel 170. In onevariation, the elongated outer sleeve 160 in each of the straight,transition and distal tip sections (180, 186 and 185, respectively) hasa diameter ranging between 4 mm and 10 mm with an overall lengthconfigured for use in hysteroscopy. More commonly, the diameter ofendoscope shaft 126 is from 5 mm to 6 mm in diameter. It has been foundthat the endoscope shaft 126 with the angled transition section 186 andoffset distal tip section 185 can be introduced through a patient'scervical canal without dilation beyond the dilation necessary for theprofile or diameter SD of the straight proximal sleeve section 180. Inother words, the tissue around the patient's cervical canal conforms tothe angles in the endoscope shaft 126 as the shaft is being advancedthrough the cervical canal.

In one variation, the handle housing 145 of endoscope component 125 isadapted for sliding, detachable engagement with the handle component 120as can be best seen in FIGS. 2 and 4. As can be easily understood, whenassembled, the operator can grip the pistol grip handle component 120with one hand and rotate the cylindrical rotating grip 152 with thefingers of the other hand to rotate the endoscope shaft and image sensor128 to orient the viewing angle of the image sensor 128 and a tool 188to any desired rotational angle. As will be described below, therotating shaft assembly 150 can be rotated at least 180° and more oftenat least 270° (FIGS. 3B and 5). In one variation, the shaft assembly 150can be rotated 360° so as to orient the image sensor 128 in anysuperior, lateral or downward direction relative to the handle housing145.

As can be seen in FIG. 2, the handle housing 145 carries a projectingelectrical connector 190A that is adapted to couple to a matingelectrical connector 190B in the handle component 120. While FIG. 2illustrates that the endoscope component 125 is configured for axialsliding engagement with the handle component 120, it should beappreciated that the angled pistol grip portion 192 of the handlecomponent 120 could plug into the endoscope component 125 in a differentarrangement, such as a male-female plug connector or a threadedconnector aligned with the axis 194 of the angled grip portion 192. Aswill be described below, the endoscope component 125 comprises a steriledevice for use in the sterile field, while the handle component 120 maynot be sterilized and is typically adapted for use in a non-sterilefield. A cable 195 extends from the handle component 120 to the baseunit 108, imaging processor 110B and controller 110A which includes apower source (see FIG. 1).

As can be seen in FIGS. 1 and 2, the endoscope component 125 includesfluid inflow tubing 200A and fluid outflow tubing 200B that communicatewith the fluid management system 105 which is shown schematically inFIG. 1. As can be understood from FIGS. 2, 3A and 3B, the endoscopehandle housing 145 can consist of two injection molded plastic shellelements, 204 a and 204 b (see FIG. 4), and FIG. 3A shows one shellelement 204 a removed to show the interior of the handle housing 145. Itcan be seen that both the inflow tubing 200A and outflow tubing 200B arecoupled to an injection molded flow channel housing 205 with an interiorbore 208 that is configured to receive a rotating core 155 of therotating shaft assembly 150.

FIG. 3B is another view similar to that of FIG. 3A with the second shellelement 204 b removed and the flow channel housing 205 also removed(phantom view) to illustrate how the stationary inflow and outflowtubing, 200A and 200B, communicate with the inflow and outflow pathwaysin the rotating shaft assembly 150 which rotates at least 180°.

Referring to FIGS. 3A and 3B, it can be seen that the rotating core 155is centrally aligned with the axis 165 of working channel 170 and isfurther coupled to the off-center elongated outer sleeve 160 of theendoscope shaft 126. The proximal end 212 of the rotating core 155 isfixed to the grip 152 for rotating the rotating core 155 in the flowchannel housing 205.

The rotating core 155 includes first, second and third flanges 218 a,218 b and 218 c which define annular flow channels 220 and 222therebetween. It can be seen that annular channel 220 is disposedbetween the first and second flanges 218 a and 218 b. Annular channel222 is disposed between the second and third flanges 218 b and 218 c.Each of the first, second and third flanges 218 a, 218 b and 218 c carryan outer O-ring 224 a, 224 b and 224 c. From the views of FIGS. 3A and3B, it can be understood how the rotating flanges 218 a-218 c rotate inthe bore 208 of the flow channel housing 205 and the O-rings 224 a-224 cmaintain a fluid tight seal between the annular flow channels 220 and222.

Again referring FIGS. 3A and 3B, it can be seen that the distal end 230a of inflow tubing 200A is fixed in the flow channel housing 205 tocommunicate with annular flow channel 222. Similarly, the distal end 230b of outflow tubing 200B is fixed in the flow channel housing 205 tocommunicate with annular flow channel 220. Thus, each of the annularflow channels 222 and 220 can rotate up to 360° and communicate with thestationary distal ends of the inflow tubing 200A and outflow tubing200B.

FIG. 3B further shows how the annular flow channels 222 in 220communicate with separate flow pathways that extend through the interiorof the elongated sleeve 160 to the working end 162 of the endoscopeshaft 126. The fluid inflow pathway can be seen in FIG. 3B which extendsthrough annular gaps AG around the exterior of inner sleeve portion 235of the rotating core 155 within the second annular channel 222. Suchannular gaps AG extend distally to communicate with the interior bore242 of the outer sleeve 160. In one variation, the pathway within saidinterior bore 242 transitions to the inflow sleeve 244 with distaloutlet 245 as shown in FIGS. 7A-7B.

The fluid outflow pathway also can be seen in FIG. 3B wherein an opening250 is provided in the inner surface of annular space 220 of therotating core 155 which communicates with the interior working channel170. Thus, the outflow pathway from a working space in one variationcomprises the working channel 170 which is fully open for fluid outflowswhen there is no tool 188 in the working channel. In FIG. 5, it can beseen that a tool seal 252 is shown in the proximal region of the workingchannel 170 that seals the channel 170 and also permits the tool 188 tobe introduced therethrough. Many types of seals are known such in theart as silicone sleeve seals, flap seals and the like. Typically, when atool is introduced through the working channel 170, the tool itself willprovide an outflow channel. Thus, the use of the working channel 170 asoutflow passageway is adapted for diagnostic procedures when using theendoscope without a tool in the working channel.

In a method of use, the endoscope shaft 126 can be navigated through apatient's end cervical canal with the inflow and outflow pumps 140A and140B (see FIG. 1) operating to provide continuous irrigation through thedistal tip section 185 of the endoscope component 125 together withendoscopic viewing by means of image sensor 128. Such a variation willthus allow fluid inflows through annular channel 222 and fluid outflowsthrough the working channel 170 and annular channel 220.

Now turning to FIGS. 7A-7B, the endoscope shaft 126 has a smallinsertion profile or configuration that consists of the outer diameterof the elongated outer sleeve 160 which includes the proximal straightsection 180, the angled transition section 186 and the distal tipsection 185 (FIG. 7A). It can be seen in FIG. 7A that the distal tipsection 185 carries an image sensor 128 and two LEDs 260 which requirean electrical connection to base unit 108, the controller 110A andimaging processor 110B. In order to provide the large number ofelectrical leads required for the image sensor 128, it was found thatconventional multi-wire electrical cables were too large to beaccommodated by the small diameter outer sleeve 160 which alsoaccommodates working channel 170, an inflow channel 244 and potentiallyother fluid flow channels. For this reason, it was found that a printedflex circuit in the form of a flat ribbon 265 (FIG. 5) could providefrom 10 to 40 electrical leads and occupy only a thin planar spacewithin the endoscope shaft 126. FIG. 7A shows the flex circuit ribbon265 extending from the image sensor 128 proximally within outer sleeve160. In one variation shown in FIGS. 3A, 3B, 5 and 7A, a second flexcircuit ribbon 270 is provided to power the LEDs 260. In anothervariation, the first flex circuit ribbon 265 could potentially carryelectrical leads to the image sensor 128 and to the two LEDs 260.

Now turning to FIGS. 3A, 3B and 5, mechanisms are illustrated thatprovide for needed slack in the electrical circuitry or flex circuitribbons 265 and 270 for accommodating rotation of the rotating shaftassembly 150 relative to the handle housing 145 (FIG. 3A). As can bestbe seen in FIGS. 3B and 5, the rotating shaft assembly 150 includes afirst or distal spool 280 around which the flex circuit ribbon 265 canbe coiled or spooled. The distal spool 280 is formed as a part of therotating core 155 of the rotating shaft assembly 150. Any suitablelength of the flex circuit ribbon 265 can be provided as needed to allowfor at least 180° rotation, or more often, 360° of rotation of therotating shaft assembly 150 relative to the handle housing 145. In thevariation shown in FIGS. 3B and 5, it can be seen that a second orproximal spool 285 comprises a portion of the rotating core 155 and isadapted for receiving a slack length of the second flex circuit ribbon270 that extends to the two LEDs 260. In FIGS. 3B and 5, it can be seenthat the proximal ends 265′, 270′ of the flex circuit ribbons 265, 270are coupled to electrical connector 190A by plug connector 288 a and 288b. While the variation of FIGS. 3A-3B shows the endoscope handleaccommodating the flex circuit ribbon 265 in a spool 280, it should beappreciated that the slack portion of the flex circuit ribbon can beconfigured with at least one of a coiled form, spiral form or foldedform without a spool.

In one aspect of the invention, referring to FIG. 7A, an endoscope shaft126 is provided that carries a distal image sensor 128 wherein thediameter of a working channel 170 in the shaft 126 is greater than 50%of the outer diameter of the shaft 126 and the electrical leads to theimage sensor 128 comprise the flex circuit 265. In such a variation, theflex circuit ribbon has a thickness of less than 0.4 mm and a width ofless than 5.0 mm. More often, the flex circuit ribbon has a thickness ofless than 0.3 mm and a width of less than 4.0 mm. Further, in thisvariation, the flex circuit ribbon carries at least 10 electrical leadsof often more than 15 electrical leads. In another aspect, electricalleads extending to the image sensor 128 are in a cable or ribbon thathas a cross-section that is less than 5% or the cross-section of theendoscope shaft 126. In another aspect of the invention, the endoscopecomprises a shaft carrying a distal image sensor, a working channelextending through the shaft wherein the working channel in a distalshaft portion is re-configurable between a constricted shape and anon-constricted shape to accommodate a tool introduced therethrough,wherein the combined diagonal dimension DD of the sensor and thediameter WCD of the working channel 170 is greater than the shaftdiameter SD in its insertion configuration or profile (see FIGS. 4, 6and 7A).

In a specific example, the image sensor 128 is available fromOmniVision, 4275 Burton Drive, Santa Clara, Calif. 95054 with the partname/number: High Definition Sensor OV9734 with a 1280×720 pixel count.The sensor 128 has package dimensions of 2532 μm×1722 μm, with adiagonal DD of 3062 μm or 3 mm. Further, the proximal shaft (outer)diameter SD is 5 mm with the working channel diameter WCD being 3 mm.Thus, the combined sensor diagonal DD (3 mm) and the working channeldiameter WCD (3 mm) equals 6 mm which is greater than the outer shaftdiameter of 5 mm. In this example, the flex circuit ribbon is 3.4 mm inwidth and 0.2 mm thickness with a cross-sectional area of 0.68 mm² whichis 3.52% of the 5 mm diameter shaft having a cross-sectional area of19.63 mm². In this specific variation, the flex circuit ribbon 265carries 19 electrical leads.

Referring again to FIGS. 7A-7B, the distal portion of the endoscopeshaft 126 includes a distal working channel portion 170′ that isre-configurable between a first smaller cross-section as shown in FIG.7A for accommodating fluid outflows and a second larger cross-section asshown in FIG. 7B for accommodating a tool 188 introduced through theworking channel 170 and its distal portion 170′.

In one variation as shown in FIGS. 3A-3B, 5, 6, and 7A, it can be seenthat the working channel sleeve 174 that defines working channel 170extends in a straight configuration through the endoscope component 125from its proximal opening port 172 to its open distal termination 290.As can be seen in FIGS. 7A and 7B, the distal end 292 of sleeve 174 hasa superior surface 294 that is straight and rigid. The working channelsleeve 174 has an inferior or lower sleeve portion 296 that is flexibleand in one variation has a living hinge portion 298 below sidewallcut-outs 302 a and 302 b in the sleeve 174. Further, the distal end ofthe endoscope shaft 126 includes an elastomeric sleeve 310 thatsurrounds the angled transition sleeve section 186, the distal tipsection 185 as well as a distal portion 312 of the proximal straightsleeve section 180 (FIG. 7B). Thus, as can be seen in FIG. 7A, theelastomeric sleeve 310 has sufficient elastic strength to collapse orconstrict the working channel portion 170′ to the smaller cross-sectionas seen in FIG. 7A.

As can be seen in FIG. 7A, the lower sleeve portion 296 includes asleeve wall 315 with sufficient curvature to maintain an open pathwaythrough the distal working channel portion 170′ when the elastomericsleeve 310 constricts the distal channel portion 170′ which therebyalways provides an open fluid outflow pathway. For example, the sleevewall 315 can have a curvature representing the same diameter as aproximal portion of sleeve 174 and extend over a radial angle rangingfrom 30° to 90°. While the lower sleeve portion 296 shown in FIG. 7Acomprises a portion of the wall of metal sleeve 174, in anothervariation, the flexible lower sleeve portion 296 may be any bendableplastic material or a combination of plastic and metal.

FIG. 7B next shows the distal working channel portion 170′ in its secondexpanded configuration as when a physician inserts an elongated tool 188(phantom view) through the working channel 170. Such a tool 188 willinitially slide along the hinge portion 298 of the lower sleeve portion296 and then stretch the elastomeric sleeve 310 to open distal workingchannel portion 170′ to allow the tool 188 to extend through the workingchannel. In other words, the elastomeric sleeve 310 will be stretched ordeformed to a tensioned position as shown in FIG. 7B as a tool isinserted through the distal working channel portion 170′. When the tool188 is withdrawn from the working channel portion 170′, the elastomericsleeve 310 will return from the tensioned position of FIG. 7B to therepose or non-tensioned position of FIG. 7A to return the workingchannel portion 170′ to the constricted configuration FIG. 7A.

In general, the endoscope component 125 corresponding to the inventionallows for the use of an image sensor 128 having a large diagonaldimension relative to the insertion profile or diameter of the endoscopeshaft 126 while at the same time providing a working channel 170 thathas a large working channel diameter WCD relative to the insertionprofile or diameter of the endoscope shaft assembly 126. More inparticular, the endoscope component 125 comprises endoscope shaft 126having a shaft diameter SD extending to a distal sleeve section 185, animage sensor 128 with a diagonal dimension DD carried by the distalsleeve section 185 and a working channel 170 having a diameter WCDextending through the elongated shaft 126, wherein the working channelportion 170′ in the distal end of the shaft 126 is adjustable in shapeto accommodate a tool 188 introduced therethrough and wherein thecombination or the sensor's diagonal dimension DD and the workingchannel diameter WCD is greater than the shaft diameter SD (see FIG.7A).

In a variation, the sensor diagonal dimension DD is greater than 50% ofthe shaft diameter SD or greater than 60% of the shaft diameter. In avariation, the working channel diameter WCD is greater than 30% of theshaft diameter, greater than 40% of the shaft diameter or greater than50% of the shaft diameter. In other words, the working channel portion170′ in the distal end is adjustable between a first cross-sectionaldimension and a second cross-section dimension. In the variation ofFIGS. 7A-7B, the working channel portion 170′ in the distal region ofthe endoscope shaft 126 is adjustable between a partially constrictedshape and a non-constricted shape.

In one variation, referring to FIG. 7A, the distal tip section 185 ofthe endoscope shaft 126 has an axial dimension D1 ranging from 5 mm to20 mm. Also referring to FIG. 7A, the angled transition sleeve section186 extends over a similar axial dimension D2 ranging from 5 mm to 20mm. Still referring to FIG. 7A, the central axis 182 of distal tipsection 185 can be parallel to and offset from the longitudinal axis 175of the straight shaft section 180 by a distance ranging from 1 mm to 10mm.

Now turning to FIG. 8, the image sensor 128 is carried in a sensorhousing 340 that also carries a lens assembly 345 as is known in theart. In one variation, the housing 340 also carries one or more lightemitters, in the variation shown in FIGS. 7A and 7B, two LEDs indicatedat 260 are shown carried in opposing sides of the sensor housing 340. Ofparticular interest, the distalmost surface 350 of the lens assembly 345and the LEDs 260 are disposed distally outward from the distal surface352 of distal tip section 185 as shown in FIG. 8. It has been found thatproviding such a distalmost surface 350 of the lens assembly and theLEDs outwardly from the distal surface 352 of distal tip section 185improves lighting from the LEDs 260 as well as improving the field ofview of the image sensor 128. The distance indicated at D3 in FIG. 7 canrange from 0.2 mm to 2.0 mm.

Now referring to FIG. 7A, another aspect of the invention comprises anoptional dedicated fluid pressure sensing channel 360 that extendsthrough a thin wall sleeve (not shown) in the endoscope shaft 126. Ascan be seen in FIGS. 7A, the distal end of the pressure sensing channel360 is open in the distal surface 352 of the endoscope shaft 126. Thepressure sensing channel 360 can extend to disposable pressure sensor inthe handle housing 145 (not shown) Such a disposable pressure sensorthen can have electrical leads coupled through the electrical connector190A in the handle housing 145 thereby send electrical signalsindicating pressure to the controller 110A (FIG. 1). Thus, in oneaspect, the disposable endoscope component 125 carries a single-usepressure sensor coupled by a detachable connector to a remote controller110A.

In one variation of a pressure sensing mechanism, referring to FIG. 7A,the wall of the pressure sensing channel 360 consists of a hydrophobicmaterial, which can be any suitable polymer such as PFTE, having aninterior diameter ranging from 0.25 mm to 2.5 mm. Often, the diameter ofchannel 360 is between 0.5 mm and 1.5 mm. It has been found that ahydrophobic surface in a pressure sensing channel 360 will prevent themigration of fluid into the channel and thereby trap an air column inthe channel communicating with the pressure sensor. The compressibilityof the air column in the pressure sensing channel 360 does notsignificantly affect the sensed pressure since the channel diameter isvery small. In another variation, a metal sleeve can be coated with ahydrophobic surface or an ultrahydrophobic surface.

Now referring to FIGS. 1, 2 and 4, it can be seen that the handlecomponent 120 has an angled pistol grip portion 192 with an axis 194that is angled from 10° to 90° away from the axis 175 of the endoscopeshaft 126. The grip portion 192 includes a finger or thumb-actuatedcontrol pad 122 that carries actuator buttons for operating all thefunctions of the treatment system, for example, including (i) operatingthe fluid management system 105, (ii) capturing images or videos fromsensor 128, (iii) adjusting light intensity from the LEDs 260, etc. Asdescribed above, the control unit 108 typically carries the imageprocessor 110B. However, the interior of the handle component 120 alsocould carry the image processor 110B or a processing component thereof.

FIG. 4 illustrated the handle component 120 and endoscope component 125from a different angle where it can be seen that the grip portion 192has a recessed channel 385 therein that is adapted to receive and lockin place the inflow and outflow tubing, 200A and 200B, so as tointegrate the tubing set with the pistol grip 192 during use. Thisfeature is important so that the inflow and outflow tubing will notinterfere with operation of the endoscope component 125 or a toolintroduced through the working channel 170. The pistol grip 192 can havea single recessed channel 385 to receive both the inflow and outflowtubing or two recessed channels for separately receiving the inflowtubing and the outflow tubing.

Now turning to FIG. 6, the enlarged view of the assembled handlecomponent 120 and endoscope component 125 shows the control pad 122 withfour actuator buttons or switches which are adapted to operate thesystem. In one variation, actuator 402 is adapted for turning on and offirrigation, or in other words actuating the fluid management system 105to provide fluid inflow and fluid outflows. Actuator 404 is adapted forimage or video capture. In a variation, momentary pressing the actuator404 will capture a single image and longer pressure on the actuator willoperate a video recording.

The actuator or scrolling button 406 has a scrolling function, whereinpressing the scrolling button 406 will cycle through various subsystems,wherein each subsystem then can be further adjusted by the centralbutton or up/down actuator 410, which is adapted for increasing,decreasing or otherwise changing an operating parameter of any selectedsubsystem. In one example, the scrolling button 406 can be actuated tocycle through the following subsystems and features: (i) fluidinflow/outflow rate from the fluid management system 105; (ii) the setpressure which is to be maintained by fluid management system 105; (iii)fluid deficit alarm which is calculated by the fluid management system105; (iv) optional selection of still image capture or video capture,and (v) LED light intensity. Then, after scrolling to select asubsystem, the physician can actuate the central up/down actuator 410 toadjust an operating parameter of the selected subsystem. As will bedescribed further below, the selection of subsystems as well as thereal-time operating parameters of each subsystem will be displayed on avideo monitor or display 112 as shown in FIG. 1. Thus, it can beunderstood that the physician may operate the scrolling button 406 toscroll through and select any subsystem or feature while observing suchas selection on the display 112, and then actuate the up/down actuator410 to adjust an operating parameter which also can be observed on thedisplay 112.

In another aspect of the invention, the controller 110A includes acontrol algorithm for operating the control pad 122 which provides ajump back to a default condition after the scroll button or actuator 406has been used by the physician. For example, the default condition willbe a selected default subsystem which is actuatable by the centralup/down actuator 410. In one variation, the default subsystem is thefluid inflow/outflow rate, which may be the subsystem most commonlyactuated by the physician to control fluid flow into and out of aworking space. As described above, the physician may use the scrollingbutton 406 to select any subsystem for adjustment of an operatingparameter. If, however, the physician does not continue to scrollbetween the various subsystems or change a parameter within apredetermined time interval, then the control algorithm will jump backto the default subsystem, which may be the fluid inflow/outflow rate.The predetermined time interval, or timeout, for the control algorithmto jump back to the default condition may be anywhere from 1 second to10 seconds, more often between 2 seconds and 5 seconds.

Still referring to FIG. 6, the assembly of the handle component 120 withendoscope component 125 is shown with a plane P to illustrate thesterile field 415 and the non-sterile field 420 relative to theendoscope assembly. As can be understood, the disposable endoscopecomponent 125 is sterilized and the physician or nurse would remove thecomponent 125 from sterile packaging which would then define a sterilefield 415. The endoscope component 125 then would be mated with thehandle component 120 which defines the non-sterile field 420. In othervariations (not shown), a plastic film or other plastic housing couldcover the handle portion 120.

A method of the invention can also be understood from FIG. 6. It can beunderstood that the physician must insert the tool 188 into the workingchannel 170 in a manner that would ensure the sterility of the tool. Ascan be seen in FIG. 6, the grip 152 which is sterile has a largediameter recess R therein which tapers into the proximal port 172 of theworking channel 170. In one variation, the diameter of the recess R isat least 15 mm and often greater than 20 mm. The depth of the recess canrange from 5 mm to 20 mm or more. Thus, it can be understood that thephysician can easily insert the distal end 425 of a tool 188 into themouth of the large diameter recess R without any risk of contacting thenon-sterile handle portion 120. Thereafter, the physician can move thetool distal end 425 distally over the surface 428 of the recess R andinto and through the port 172 of the working channel 170. By using thismethod, the physician can be assured that the tool 188 will not contactthe non-sterile field 420.

Now turning to FIG. 9, another aspect of the invention is shown whichrelates to electronic mechanisms carried by the endoscope 500 forre-orienting the image on the display in response to rotation of theendoscope shaft 510 to ultimately provide an image-upright configurationon the display. In one variation, an accelerometer 515 (which cancomprise an accelerometer gyroscope combination) is provided which cansend signals to a controller and image processor related to rotation ofthe endoscope shaft 510. For example, an STmicro IIS2DH 3-axisaccelerometer can be used or a 6-axis IMU (Inertial Motion Unit) with 3accelerometer and 3 gyroscope axis such as an STmicro ISM330DLC can beused.

The image processor in the controller then can use the accelerometersignals to calculate a necessary amount of rotational correction for theimage re-orientation. The calculation includes the degree of rotation ofthe shaft 510 relative to the longitudinal axis 518 of the shaft 510.The image is then electronically rotated to display on any video displayor monitor can be carried by the handle of the device or most often is aremote display. Thus, the video image on the display can at all times bein an image-upright configuration for viewing by the physician.

As can be seen in FIG. 9, the accelerometer 515 is carried on theproximal spool 285 which is rotatable within the handle assembly 520.Thus, any rotation of the rotating component 522 independent of thehandle 524 or rotation of the handle 524 relative to the longitudinalaxis 518 of the shaft will be sensed by the accelerometer 515 to thusallow reorientation of the image on the display. In the variation ofFIG. 9, a second accelerometer 540 is carried on the circuit board 545which is fixed in the non-rotating handle 524. Thus, signals from thisaccelerometer 540 provide signals of rotation of the handle only. In onevariation, signals from both accelerometers 515, 540 can be compared todetermine rotation of the rotating component relative to the handle 524.In one aspect, signals from the second accelerometer 540 can be used ifsignals from the first accelerometer 515 fail for any reason. An alerton the display can indicate to the user if either the first or secondaccelerometer has failed to perform properly.

FIGS. 10 and 11 illustrate another variation of an endoscope working end550 which is similar to the previous embodiment. The thin-wall outersleeve 552 is in phantom view in FIG. 10 and the thin-wall workingchannel sleeve 554 is shown. As described previously, electronic signalsfrom the image sensor 555 (FIG. 11) as well as power for the imagesensor and LEDs 558A and 558B are carried in a flex circuit 560extending through the shaft 510 of the endoscope. Since the endoscopeshaft 510 will be operating in a fluid environment, it has been foundthat significant RF shielding is needed around the signal-carryingelectrical conductors in the flex circuit 560 to ensure that potentialelectrical devices introduced through the working channel 564 will notgenerate electrical fields that may interfere with signals carried inthe flex circuit 560.

Thus, in one variation shown in FIG. 10, the flex circuit may be anedge-coupled stripline design where two outer dielectric layers 562 aand 562 b carry electrical conductors 565 (including ground planes) andare configured to function as a shield relative to the electricconductors 570 disposed in a middle layer 572 between the two outerlayers 562 a and 562 b. In this variation, the plurality of electricconductors 570 disposed in the middle layer 572 are adapted to carry allthe signals from the image sensor 555. Thus, the two outer layers 562 aand 562 b function as a shield to prevent any potential interferencefrom electrical tools that might interfere with the signals carried bythe interior conductors 570 in the middle layer 572.

In one variation, the signal carrying conductors 570 in the middle layer572 are provided with a dielectric insulator layer on both sides thathas a thickness of at least 0.0005″, at least 0.001″ or at least 0.002″.The insulator layers can be any suitable power material such Kapton.

In some variations, the number of electrical conductors 570 that carryimage signals in the middle layer 772 can vary from 4 to 24 or more andtypically range from 12 to 20 conductors. In this variation, theelectrical leads to the LEDs 558A and 558B are also carried in themiddle layer 572 which could be subject to interference from anelectrical tool. Thus, providing the electrical leads and signalconductors in the middle layer 572 in the stripline design allows for anoverall flex circuit 560 that is thinner and more flexible than otherconfigurations that provide adequate RF shielding.

Now turning to FIGS. 11-13, the endoscope shaft working end 550 issimilar to that of FIGS. 7A and 7B. In the variation of FIG. 11, theshaft working 550 end has a secondary flexible hinge portion 580 whichallows for changing the angle of the field of view FOV of the imagesensor 555 about its axis 572. For introduction into a working site inthe patient's body, the working end 550 of the shaft 510 has a distalsegment 585 that has an axis 588 that is angled relative to thelongitudinal axis 590 of the shaft 510 at a selected angle which can befrom 5° to 30°. It can be seen in FIG. 11 that a second or intermediatesegment 595 of the working end 550 includes a living hinge portion 580which allows it to flex relative to the proximal shaft segment 600. Theintermediate segment 595 and distal segment 585 are fixed together at anangle which can be seen in FIGS. 11 and 12A. The mechanism for actuatingthe distal segment 585 and intermediate segment 595 to a flexed position(see FIG. 12B) consists of inserting an elongated tool body or shaft 604through the working channel 564 as described previously.

FIGS. 12A and 12B are schematic transparent views of the working end 550of FIG. 11 showing the interior working channel 564 and the proximalshaft segment 600, the intermediate shaft segment 595 and the distalshaft segment 585. In FIG. 12 B, it can be seen that the elongated toolbody 604 (phantom view) has been inserted through the working channel564 which causes multiple effects. First, as described previously, theelongated tool shaft 604 stretches the resilient silicone sleeve 610around the working end 550 (FIG. 11) to expand the working channel 564from a collapsed condition to an expanded condition. At the same time,the introduction of the tool shaft 604 through the working channel 564flexes the proximal hinge 580 at the proximal end of the intermediatesegment 595 to cause the intermediate and distal segments 595 and 585 toflex away from the repose position (FIG. 12A) to a tensioned position(FIG. 12B) wherein the axis 588 of the image sensor 555 is parallel tothe longitudinal axis 518 of the proximal shaft portion 600. In thisflexed position of FIG. 12B, the image sensor 555 then is aligned withthe longitudinal axis 518 of the shaft and the sensor axis 572 and theangle of the field of view FOV then can be 0° relative to thelongitudinal axis 518 of the shaft.

In this variation shown in FIG. 11, it can be seen that the tensioningsupport sleeve 625 is shown which partially surrounds the proximalendoscope shaft portion 600 and sleeve segment 595. More in particular,the support sleeve 625 has an upper surface 628 that is fixed to theadjacent upper surface 630 of the proximal shaft portion 600. Thesupport sleeve 625 has a longitudinal discontinuity 626 therein and thesleeve extends around the shaft from about 200° to 360°. It can furtherbe seen in FIG. 11 that the support sleeve with a length LL whichextends over a portion of the proximal shaft 600 and over a portion ofthe intermediate sleeve 595. As can be seen in FIGS. 11 and 13, theinterior portion of the support sleeve 625 has the longitudinal gap ordiscontinuity 626 which allows the side portions 640 a and 640 b to beflexed outwardly when an elongated tool shaft 604 is introduced throughthe working channel 564. In this aspect, the support sleeve 625functions as a spring which urges the support sleeve 625 radiallyinwardly to return the endoscope shaft 510 to a straight configurationwhen the tool shaft 604 is removed from the working channel 564.

In another aspect of the invention referring to the exploded view ofFIG. 13, it can be seen that the distal end of the distal shaft segment595 includes a housing 650 that carries both the image sensor 555 andfirst and second LEDs 558A and 558B. The housing 650 can be molded outof any suitable polymer and includes means for providing flex circuitconnections to both the image sensor 555 and the LEDs. An upper guidesurface 655 is coupled to the sensor housing 650 to provide a slidinginterface against which the tool shaft 604 can push and deflect thedistal segment 595 and sensor housing 650. A lower guide surface 660 iscoupled by a flexible element 664 to the working channel sleeve 554 toprovide a sliding interface against which the tool shaft 604 can openthe working channel 564 without contacting the silicone sleeve 610 (seeFIG. 11).

Now turning to FIGS. 14 through 17B, another variation of components ofan endoscope working end 700 is shown which includes a distal housing704 that carries an image sensor 705 (FIG. 17B) and lens stack 708together with a flex circuit 710 that is configured for coupling to theimage sensor as well as two LEDs 715A and 715B. In one aspect of theinvention, the elongated flex circuit 710 is adapted to be carried inthe interior of the endoscope shaft or sleeve 720 in a channel that canbe used for fluid inflows and fluid outflows. Thus, the flex circuit 710and its connections to the image sensor and LEDs are entirely insulatedto allow for its use when submerged in such fluid flows.

FIG. 14 is perspective view of the housing 704 and lens assembly orstack 708 in the distal working end 700 of an endoscope similar to thatof FIGS. 10, 11, 12A and 12B. It can be seen that a single flex circuit710 is shaped for folding to allow the image sensor 705 and the LEDs715A, 715B to be oriented distally or aligned with the longitudinal axis722 of the endoscope shaft. Thus, the multiple electrical leads to theimage sensor 705 and to two LEDs that can be provided in a single flexcircuit which conserves space in the endoscope shaft which is criticallyimportant.

FIG. 15 is perspective view of the distal portion of the flex circuit710 of FIG. 14 in an exploded view showing the five thin film layersthat comprise of the flex circuit 710 in a planar form before bondinginto the single component. The first layer 725A or layer 1 comprises athin-film insulator layer which covers the electrical leads in thesecond layer 725B or layer 2. A central portion of the distal end of thelayer 1 indicted at 725A includes an open port 728 that exposes theelectrical leads in layer 2 (725B) for coupling to the image sensor 705as shown in FIG. 17A. It can be seen in FIG. 15 that layers 1 through 4of the flex circuit 710 are configured with first and second legs 730Aand 730B that extend laterally or perpendicular to the axis 732 of theflex circuit which are adapted to couple to the LEDs as will bedescribed below.

The second layer 725B or layer 2 of the flex circuit carries a pluralityof electrical leads 735 that extend to the image sensor 705. Layer 3indicated at 725C of the flex circuit carries a planar ground element740. Layer 4 indicated at 725D of the flex circuit carries additionalelectrical leads 742 coupled to the image sensor 705 as well as leadsthat couple the two LEDs in a series connection. Layer 5 indicated at725E of the flex circuit 710 does not have a shape withlaterally-extending legs 730A and 730B corresponding to the shape of thelayers 1 through 4. Layer 5 is configured as a stiffener layer with adistal end 748 that defines a bending region 750 extending transverselyacross the flex circuit 710 to provide a bending line for layers 1through 4 when bonded together (FIGS. 17A-17B).

In FIG. 15, it can be seen that layers 1 through 4 (725A-725D) includenotch features for inducing bending of the flex circuit at selectedlocations. More in particular, notch features 755 provided on eitherside of the flex circuit 710 define a transverse line to induce bendingof the flex circuit perpendicular to the longitudinal axis 732 as can beseen in FIGS. 17A and 17B. The laterally-extending legs or segments 730Aand 730B also include notches 758 which are adapted to induce bending ofsuch laterally-extending segments as also can be seen in FIGS. 17A and17B.

FIG. 16 shows the proximal ends of layers 1 through 4 (725A′-725D′) ofthe flex circuit 710 in an exploded view with layer 1 (725A′) having anopen port 760 to expose the electrical connection points 762 in layer 2(725B′) which are adapted for coupling to a circuit board in theendoscope handle (not shown).

FIG. 17A is perspective view of the distal portion of the flex circuit710 of FIG. 15 showing the image sensor 705 and the LEDs 715A, 715Bcoupled to the flex circuit. In addition, it can be seen that thelaterally extending segments 730A and 730B are folded 90° away from theplanar shape of the flex circuit as in its manufactured form shown inFIG. 15. The axis 765 of the field of view (FOV) of the image sensor isalso shown. FIG. 17B then shows the transverse bending of the flexcircuit 710 which then orients the axis 765 of the image sensor's fieldof view and the light transmission axes 770 of the LEDs in the distaldirection. Thus, FIG. 17B is a schematic view of the components in theworking end 700 of FIG. 14 where FIG. 17B does not show the lens housing704 or the lens stack 708 with the outer sleeve 720 in phantom view.Referring to FIG. 14, it should be appreciated that the outer or distaltips 780 of the laterally extending segments 730A and 730B can be foldedinwardly at point 782 (FIGS. 14 and 15) to attach to the proximalsurface of the LEDs 715A, 715B or can be adapted to couple to the sideof the LEDs or a circuit component attached to the LEDS as in FIGS. 17Aand 17B.

In general, a flex circuit for an endoscope corresponding to theinvention comprises an elongated flexible circuit manufactured to extendin a planar shape to a distal end having first and second flex elementsadapted to bend away from the planar shape, an image sensor having afield of view (FOV) axis operatively coupled to a surface of the firstflex element, and an LED with a light axis operatively coupled to asurface of the second flex element, wherein the first and second flexelements are capable of bending away from the planar shape to anon-planar shape for coupling to an endoscope shaft or housing where theFOV axis and light axis are in a distal-facing orientation afterbending.

In another aspect, a flexible circuit assembly of the inventioncomprises an elongated flexible circuit member, an image sensor and atleast one LED coupled to a distal portion of the flexible circuit memberin a first spaced apart configuration, wherein said distal portion isconfigured for deformation or folding to dispose the image sensor andthe at least one LED in a second spaced apart configuration for couplingto a distal housing of an elongated endoscope shaft that carries a lensor lens stack for the image sensor.

In another aspect a flexible circuit of the invention comprises anelongated flat flexible circuit member extending in a plane from aproximal end to a distal end and an image sensor operatively coupled toa first surface of the flexible circuit member where the sensor field ofview is orthogonal to said first surface wherein a distal portion of theflexible circuit member carrying the image sensor is configured forflexing away from said plane for coupling to a distal portion of anelongated endoscope shaft to thereby re-orient the sensor field of viewat an angle relative to the plane of the flex circuit member.

FIG. 18 illustrates another embodiment of an endoscope 800 similar tothat of FIGS. 1 to 4, except this new variation of FIG. 18 has adifferent working end portion 805. As can be seen in FIG. 18, theendoscope 800 again has a handle portion 806 coupled to an elongateshaft assembly 808 that extends along a longitudinal axis 810 to theworking end portion 805. In this variation, the working end portion 805includes an elastomeric structure or body 815 that includes an imagesensor 816 therein and at least one LED 818. In the variation of FIG.18, two LEDs 818 are shown. The elastomeric body 815 can be silicone ora similar biocompatible material. The elastomeric body 815 is adapted tohave linear shape in the repose or non-tensioned state of FIGS. 18 and19A which provides the elongated shaft assembly 808 with an insertionprofile having a small diameter for introducing through a patient'scervical canal into the uterus. Inflow and outflow pumps 140A and 140Bare provided and are adapted to provide fluid inflows and outflows asdescribed previously.

Referring to FIGS. 18 and 19A, the image sensor 816 and LEDs 818 arecarried by a sensor housing 820 which can be molded out of a plastic andcarries a lens or lens stack 824 in front of the image sensor 816. TheLEDs 818 are positioned on either side of the lens housing 820.Referring to FIG. 19A, the image sensor 816 and LEDs 818 are coupled toa flex circuit 840 as described previously with reference to FIGS.14-17B. The flex circuit 840 is entirely waterproof as fluid inflowsfrom the fluid source and inflow pump 140A can be used to provide fluidinflows through the interior space 876 carrying the flex circuit.

FIG. 19A shows the working end portion 805 of FIG. 18 in an enlargedview where the elastomeric body 815 is transparent to show the interiorcomponents of the working end portion 805. As can be seen in FIGS. 18and 19A, the elongated shaft assembly 808 comprises a rigid outer sleeve844 which can be any suitable thin wall material such as a stainlesssteel or a plastic material. Typically, the outer sleeve 844 has adiameter ranging from 4 mm to 6 mm but dimensions are possible. In FIGS.19A and 19B, it can be seen that a working channel sleeve 845 with aworking channel or passageway 848 therein is carried within the outersleeve 844.

The elastomeric body 815 has a proximal portion 850 that may be formedor molded to tightly fit over the distal end portion 852 of the outersleeve 844. The elastomeric body 815 can be bonded to the outer sleeve844 with adhesives or other suitable means. The distal portion 855 ofthe elastomeric body 815 extends beyond, and is not supported by, thedistal end portion 852 of the outer sleeve 844 and thus can be deformedas shown in FIGS. 19A and 19B to (i) allow for re-positioning of thesensor housing 820 and (ii) contemporaneously allow for expansion of theworking channel portion 860 in the elastomeric body 815 as a tool shaft872 (FIG. 18) is introduced through the working channel 848.

Referring again to FIG. 19A, the elastomeric body 815 is shown in aninsertion profile of the shaft assembly 808 wherein the elastomeric body815 collapses the working channel portion 860 therein. In FIG. 19A, itthus can be seen that the working channel 848 in the rigid sleeve 445transitions to the expandable-collapsible working channel portion 860 inthe elastomeric body 815. The distal end 862 of the working channelsleeve 845 is connected to a working channel portion 860 in theelastomeric body 815 by adhesives or other suitable means. In FIG. 19A,the distal termination 870 of the working channel portion 860 is shownin the collapsed state as the elastomeric body 815 is in its repose,linear shape. In FIG. 19B, a shaft 872 of a tool is shown beingintroduced through the working channel portion 860 in the elastomericbody 815 which stretches and expands the working channel portion 860.

In the variation shown in FIGS. 19A and 19B, the flex circuit 840extends through the space 876 between the working channel sleeve 845 andthe interior surface 878 of the outer sleeve 844. As will be describedfurther below, the flex circuit 840 and the elastomeric body 815function together as supporting structures to maintain the sensorhousing 820 in a selected orientation both when the elastomeric body 815is in its repose position and a tensioned position.

In FIG. 19A, it can be understood that the elastomeric body 815 isconfigured to engage and carry the sensor housing 820 in a selectedorientation or viewing angle VA relative to the longitudinal axis 810 ofthe shaft assembly 808. In one variation, the optical axis 875 of theimage sensor 816 and lens 824 is angled away from the longitudinal axis810 of the shaft assembly a viewing angle VA of from 15° to 45° which isoptimal for introducing in the endoscope shaft assembly through acervical canal. With such a viewing angle VA, the physician canthereafter rotate the shaft and field of view in 360° to observe allparts of a uterine cavity following introduction through the cervicalcanal.

In FIG. 19B, it can be seen that introducing the tool shaft 872 throughthe working channel portion 860 in the elastomeric body 815 displacesthe sensor housing 820 outwardly relative to the longitudinal axis 810of the shaft assembly 808 and at the same time alters the angle of theoptical axis 875 of the image sensor 816 and lens 824 to a lesser anglewhich is optimized for viewing the working end of the tool during inuse. The working end of the tool can consist of a resecting device, abiopsy tool, a forceps or the like (not shown). In one variation asshown in FIG. 19B, the viewing angle VA is from 0° to 15° when theelastomeric body 815 is in the deflected or tensioned shape.

In another aspect of the invention, it can be understood that the flexcircuit 840 functions as a support for the sensor housing 820 to therebymaintain the sensor housing in a selected relationship with the outersleeve 844. In other words, the flex circuit 840 functions as a livinghinge and flexes within the shaft assembly 808 at the same timepreventing any axial movement of the sensor housing 820. Thus, thecombination of the flex circuit 840 and the elastomeric body 815provides structural support for moving the sensor housing 820 in a planebetween the repose and tensioned shapes of the elastomeric body 815 (seeFIGS. 19A and 19B).

Now turning to FIGS. 20A and 20B, the elastomeric body 815 of FIGS.19A-19B is shown separated from the shaft assembly 808 to betterillustrate the features of one variation of a molded elastomeric body815. In FIG. 20A, it can be seen that the proximal portion 850 has abore 877 extending therethrough for tightly fitting over the outersleeve 844 as described above. In the cut-away view of FIG. 20B, it canbe seen that the distal working channel portion 860 of the elastomericbody 815 is configured with a proximal end 879 that couples to theworking channel sleeve 845 in the shaft assembly 808 (see FIG. 19A). InFIG. 20B, it can be understood that the inferior portion 880 of theelastomeric body 815 that transitions upwardly into the working channelsurface 884 can slide into a longitudinal slot (not shown) in the outersleeve 844 to couple the elastomeric body 815 to the outer sleeve 844.In FIGS. 20A and 20B, it can be understood that the working channelportion 860 in the elastomeric body 815 is thus expandable andcollapsible as illustrated in FIGS. 19A and 19B. In another aspect,referring to FIGS. 20A-20B, the elastomeric body 815 has projectingfeatures 885 molded therein which are adapted to engage and gripreceiving features (not shown) in the sensor housing 820 to therebymaintain the sensor housing 820 in a fixed rotational orientationrelative to the elastomeric body 815.

In another aspect of the invention shown in FIGS. 20A and 20B, asuperior portion 890 of the elastomeric body 815 comprises a thin-wallmaterial which can be more elastic than the inferior portion of theelastomeric body indicated at 892. Thus, the superior portion 890 is farmore elastic which assists in the deformation of the elastomeric body815 as shown in FIG. 19B.

In another aspect of the invention, referring to FIGS. 19A-19B, it canbe seen that the sensor housing 820 has a longitudinal groove or channel895 in its inferior surface 896 which cooperates with a shaft 872 of atool being introduced through the working channel portion 860. Thelongitudinal groove 895 maintains movement of the sensor housing 820 ina single plane and prevents any side-to-side movement of the opticalaxis 875 of the lens 824 and image sensor 816. In other words, thelongitudinal groove 895 in the sensor housing 820 contacts and engagesthe tool shaft 872 as the elastomeric body 815 is deformed from therepose position of FIG. 19A to the tensioned position of FIG. 19B. Inthis variation, the fluid source and inflow pump 140A can provide fluidinflows into a treatment site through the space 876 between the workingchannel sleeve 845 and the interior surface 878 of the outer sleeve 844(FIGS. 19A and 19B) which extends through space 898 around the sensorhousing 820.

While the above variations illustrate the elastomeric body 815 beingmoved or actuated from the repose position to its tensioned position bymeans of the tool shaft 872, it should be appreciated that the actuationmechanism for actuating elastomeric body 815 can also comprise a workingchannel sleeve that is translatable from a proximal position to a moredistal position to move the elastomeric body from the repose shape ofFIG. 19A to the tensioned shape of FIG. 19B. In another variation, apull-wire as is known in the art can be used as an actuation mechanismto actuate elastomeric body 815 between the repose and tensioned shapes.

Now turning to FIG. 21, another variation of elastomeric body 905 isshown wherein the distal working channel portion 906 is within aflexible working channel sleeve 908 and not molded into the elastomericbody 905 itself. In FIG. 21, the elastomeric body 905 has a proximalportion 910 that is configured to couple to the distal end 852′ of anouter sleeve 844′ as in the previous embodiment. In this variation, theworking channel sleeve 908 comprises a thin-wall polymeric sleevewherein at least its distal portion is collapsible and expandable. As inthe previous embodiment, it can be understood that the interior channel906 is expandable when a tool shaft (not shown) is insertedtherethrough. In this variation, the entire length of the workingchannel may be the polymeric sleeve 908 extending through the shaftassembly. Alternatively, only a distal portion of sleeve 908 can beflexible and connected to a rigid metal or polymer working channelsleeve in the shaft assembly similar to that shown in FIGS. 19A and 19B.In the variation of FIG. 21, the working channel sleeve 908 can be alubricious polymer such as Teflon or a similar fluoropolymer.

Still referring to FIG. 21, the distal region 922 of the working channel906 is configured with features or elements 925 to maintain the workingchannel 906 in a collapsed but partially open or constricted openconfiguration. In the non-constricted open configuration, a tool shaftintroduced through the channel simply slides over the elements 925. Suchelements 925 can be projecting ribs or other projections adapted toprevent the complete collapse and sealing off of the channel 906.Alternatively, stiffening elements can be provided or formed in thewalls of the sleeve 908 to maintain a radius that is not collapsible.The purpose of maintaining a slightly open working channel 906 is toprovide an outflow pathway in communication with the outflow pump 140B(see FIG. 21) so that both inflows and outflows are provided during usewithout a tool in the working channel to thereby allow for maintaining aset pressure in a treatment site. It should be appreciated that suchelements 925 also can be provided in the working end variation shown inFIGS. 18-19B to provide a constricted open channel. In the variationshown in FIG. 21, the inflow pump 140A provides fluid inflows from aremote fluid source into a treatment site through the space 876′ betweenthe working channel sleeve 908 and the interior surface 878′ of theouter sleeve 844 which extends to a space 898 around the sensor housing820 as described above (see FIGS. 19A-19B).

In general, an endoscope corresponding to the invention comprises anelongated shaft extending about a longitudinal axis to a distalelastomeric body that is deformable between a repose shape and atensioned shape and an image sensor disposed within the elastomeric bodywherein the repose shape of the elastomeric body provides the imagesensor with a first viewing angle and the tensioned shape of theelastomeric body provides the image sensor with a second viewing angle.In this variation, the first viewing angle is between 15° and 45° andthe second viewing angle is between 0° and 15°. The actuation mechanismfor moving the elastomeric body between the repose shape and thetensioned shape typically comprises a tool shaft. In other variations, apull-wire or a translatable sleeve can be used to actuate elastomericbody. In one variation, the cross-section of the passageway four workingchannel when expanded in the tensioned shape is at least 40% of thediameter of the elongated shaft. In other variations, the cross-sectionof the passageway when expanded is at least 50% or at least 60% of thediameter of the elongated shaft assembly.

In general, an endoscope corresponding to the invention comprises anelongated shaft with a working channel extending about a longitudinalaxis to a distal elastomeric body with an image sensor within theelastomeric body, wherein the elastomeric body has a repose shape inwhich the working channel has a collapsed cross-section and isdeformable to a tensioned shape in which the working channel has anexpanded cross-section for accommodating a tool introduced therethrough.

In general, an endoscope corresponding to the invention comprises anelongated shaft with an image sensor carried in a distal elastomericportion thereof, wherein the shaft has an insertion profile with theelastomeric portion in a repose shape, and an image sensor with adiagonal dimension carried in the elastomeric portion, wherein theelastomeric portion is deformable from the repose shape to a tensionedshape to provide a working channel therein from a collapsedcross-section to an expanded cross-section, and wherein the combinationof the sensor diagonal dimension and the expanded-cross sectiondimension is greater than the cross-sectional dimension of the insertionprofile. The sensor diagonal dimension typically is at least 30% of thecross-sectional dimension of the insertion profile. In other variations,the sensor diagonal dimension is at least 40% or at least 50% of thecross-sectional dimension of the insertion profile.

In general, an endoscope corresponding the invention comprises anelongated shaft extending to a distal elastomeric body, an image sensorand LED carried in the elastomeric body, and a flex circuit extendingthrough the elongated shaft coupled to the image sensor and LED whereinthe elastomeric body is deformable from the repose shape to a tensionedshape to adjust a working channel therein from a collapsed cross-sectionto an expanded cross-section. In this variation, the flex circuit isadapted to support the image sensor in combination with the elastomericbody.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

1. (canceled)
 2. An endoscope for use with a tool shaft, the endoscopecomprising: an elongated shaft extending about a longitudinal axis andhaving a diameter and a shaft passage extending therethrough, theelongated shaft comprising an outer sleeve; a working channel sleeveextending within the elongated shaft and having a working channel; anelastomeric body at a distal end of the elongated shaft, the elastomericbody having a bore in fluid communication with the shaft passage, theelastomeric body including a working channel portion that is in fluidcommunication with the working channel and is deformable between acollapsed configuration and an expanded configuration; a sensor housingpositioned within the elastomeric body; an image sensor and at least oneLED disposed within the sensor housing; and wherein advancement of thetool shaft through the working channel and into the working channelportion moves the working channel portion from the collapsedconfiguration to the expanded configuration.
 3. The endoscope of claim2, wherein the image sensor comprises a first viewing angle relative tothe longitudinal axis, wherein advancement of the tool shaft through theworking channel and into the working channel portion moves the imagesensor from the first viewing angle to a second viewing angle relativeto the longitudinal axis.
 4. The endoscope of claim 3, wherein the firstviewing angle is greater than the second viewing angle.
 5. The endoscopeof claim 2, wherein a proximal portion of the elastomeric body issecured to a distal end of the elongated shaft.
 6. The endoscope ofclaim 2, further comprising a flex circuit between the working channelsleeve and the outer sleeve.
 7. The endoscope of claim 6, wherein theimage sensor is coupled to the flex circuit, wherein the flex circuit isadapted to deflect as the elastomeric body moves between the collapsedconfiguration and the expanded configuration.
 8. The endoscope of claim7, wherein the flex circuit is coupled to the at least one LED.
 9. Theendoscope of claim 8, wherein the flex circuit comprises a flexiblehinge adapted to support the sensor housing and image sensor incombination with the elastomeric body.
 10. The endoscope of claim 2,wherein a space between the working channel sleeve and an interiorsurface of the outer sleeve allows fluid to flow therethrough.
 11. Theendoscope of claim 2, further comprising an actuation mechanism formoving the elastomeric body between the collapsed configuration and theexpanded configuration.
 12. The endoscope of claim 11, wherein theactuation mechanism comprises an actuation member that is axiallymoveable in the elongated shaft to deflect a portion of the elastomericbody.
 13. The endoscope of claim 12, wherein the actuation membercomprises the tool shaft.
 14. The endoscope of claim 12, wherein theactuation member comprises the working channel sleeve.
 15. The endoscopeof claim 2, wherein the elastomeric body has a superior wall portionthat is more deformable than an inferior wall portion thereof.
 16. Theendoscope of claim 15, wherein the inferior wall portion of theelastomeric body transitions upwardly into the working channel andslides into a longitudinal slot in the outer sleeve to couple theelastomeric body to the outer sleeve.
 17. The endoscope of claim 2,wherein the elastomeric body comprises projecting features moldedtherein configured to engage receiving grooves in the sensor housing tomaintain the sensor housing in a fixed rotational orientation relativeto the elastomeric body.
 18. The endoscope of claim 2, wherein theelastomeric body in the collapsed configuration has a passagewayextending therethrough with a collapsed cross-section and in theexpanded configuration the passageway has an expanded cross-section. 19.The endoscope of claim 18, wherein the expanded cross-section of thepassageway when expanded in the expanded configuration is at least 40%of the diameter of the elongated shaft.